A Comparative Effectiveness Study of Positive Airway Pressure (PAP) Therapy, Dental Device, and Atomoxetine-Oxybutynin for Treatment of Obstructive Sleep Apnea in Adults

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorSairam Parthasarathy

About this trial

Researchers want to identify which treatments for obstructive sleep apnea (OSA) work best and are easiest for patients to use consistently. Eligible participants will be randomly assigned one of three OSA treatments: traditional PAP therapy, a dental device, or a combination of two FDA-approved medications (atomoxetine and oxybutynin) that are currently approved for other conditions. Over the course of one year, participants will attend two in-person visits and take part in four phone check-ins to complete surveys, report any side effects, and discuss how well they are following their assigned treatment.

Eligibility criteria

Qualifiers

Obstructive sleep apnea (AHI >/= 5 per hour), diagnosed in the past 6 months

Two or more of the following symptoms: snoring, fragmented sleep, witnessed apneas, or daytime sleepiness

Willingness/ability to use any of the 3 treatments for OSA (PAP, dental device, or atomoxetine-oxybutynin)

Health insurance of any type

Disqualifiers

Prior treatment for OSA in past year

Central sleep apnea or narcolepsy

Contraindication for dental device (temporomandibular joint problems, severe periodontal disease, insufficient dentition)

Heart failure with reduced ejection fraction of </= 45%

Trial design

Treatments tested in this trial

  • Positive airway pressure (PAP) therapy
  • Sleep dental device
  • Atomoxetine-oxybutynin

Treatment groups

2,400 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Sairam Parthasarathy

Lead sponsor

University of Arizona

Sponsor institution

Patient-Centered Outcomes Research Institute

Collaborator

University of Arizona

Collaborator

University of Maryland

Collaborator

University of Miami

Collaborator

Stanford University

Collaborator